Evaluation of a Decision Aid for Deep Brain Stimulation Surgery for Parkinson's Disease

NCT ID: NCT06446505

Last Updated: 2024-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2026-07-31

Brief Summary

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The goal of this clinical trial is to learn if a Decision Aid can help patients with Parkinson's disease make a decision about undergoing Deep Brain Stimulation surgery. The main questions it aims to answer are:

* Is the Decision Aid acceptable to patients with Parkinson's disease considering Deep Brain Stimulation surgery?
* Does the decision aid improve decision quality (informed, value-based decision) and uncertainty about the decision?

Researchers will compare immediate use of the decision aid during the evaluation process for deep brain stimulation surgery to delayed introduction of the decision aid.

Participants will:

* Receive the decision aid at the beginning of the evaluation process or towards the end
* Complete surveys at 5 visits (remote or in-person) over approximately 6 months

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Early Decision Aid

Participants will receive the Decision Aid at baseline.

Group Type EXPERIMENTAL

Deep Brain Stimulation Decision Aid

Intervention Type OTHER

An online decision support tool that provides education about deep brain stimulation and the alternatives, and includes value clarification exercise.

Delayed Decision Aid

Participants will receive the Decision Aid at the end of the deep brain stimulation surgery evaluation process.

Group Type ACTIVE_COMPARATOR

Deep Brain Stimulation Decision Aid

Intervention Type OTHER

An online decision support tool that provides education about deep brain stimulation and the alternatives, and includes value clarification exercise.

Interventions

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Deep Brain Stimulation Decision Aid

An online decision support tool that provides education about deep brain stimulation and the alternatives, and includes value clarification exercise.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults with a diagnosis of Parkinson's disease referred for deep brain stimulation surgery evaluation at the University of Colorado

Exclusion Criteria

* Atypical Parkinsonism
* Diagnosis of Dementia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle E Fullard, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anschutz

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michelle E Fullard, MD

Role: CONTACT

3037242194

Erika Shelton

Role: CONTACT

3037244644

Facility Contacts

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Michelle E Fullard

Role: primary

303-724-2194

Erika Shelton

Role: backup

3037244644 ext. Fullard

Other Identifiers

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K12AR084226

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-2390

Identifier Type: -

Identifier Source: org_study_id

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